1. Field of the Invention
The present invention relates to a quality control system for use in an automated analyzer for analyzing components contained in a biological sample, and more particularly to a quality control system that uses the result of measuring a standard solution.
2. Description of the Related Art
An automated analyzer used for clinical laboratory tests measures patients/samples to analyze items requested by a doctor. As a control technique for controlling such an analyzer, a quality control sample (control sample) whose concentration is known is periodically measured during intervals between measurements of patients/samples. If the concentration of measured data deviates from the concentration included in the control sample, the analyzer issues an alarm indicating that the data is abnormal. By measuring the control sample, it is possible to check whether or not the analyzer is abnormal on the day, to check the aging of a reagent, to judge whether or not the analyzer is sufficiently adjusted, and to judge whether or not the standard solution can be adjusted. The result of calibration, and the result of measuring the control sample, are summarized by a clinical laboratory technologist, and are then recorded and stored.
A control technique for controlling a control sample includes control performed by a clinical laboratory technologist of a hospital's clinical laboratory. Besides this technique, the multiple systems described below have already been developed and are on sale, or are implemented in public institutions.
1. Control Technique that Uses a Control Sample
Examples of a technique for distributing control samples to each hospital to control the control samples include a system that is sold by a reagent manufacturer and public institutions such as a medical association.
(1) Quality Control that Uses a Control Sample Supplied by a Reagent Manufacturer
A reagent manufacturer sells, as a control sample, serum or the like whose value has already been determined to hospitals and the like. In each of the hospitals, each control samples is provided with an average value, a standard deviation used as an indicator of variations, and the like, all of which have already been determined. These values are inputted into an analyzer, or a computer used for data management in each hospital.
An automated analyzer used for clinical laboratory tests measures patients/samples to analyze items requested by a doctor. A control sample is periodically inputted during measurements of patients/samples, and thereby data is measured. If the measured data deviates from data that has already been measured, it is judged that the data is abnormal, and accordingly a check is made as to whether or not the analyzer, the reagent, the standard solution, or the like, is abnormal. A clinical laboratory technologist summarizes the measured data, and records daily fluctuations in data.
(2) In the Case where a Reagent Manufacturer Sells Control Samples, Receives Measured Results (Data) Through a Network Line, by Mail, or the Like, and Manually Summarizes the Data
In the above-described method (1), there is also a system in which the reagent manufacturer supplies control samples, and collects values thereof from each individual hospital, and then summarizes the values in, for example, a service center of the reagent manufacturer. Data from the automated analyzer is not directly summarized. The results of measurements are transmitted through the network line; and data of the control samples is transmitted from a general personal computer. Data of the control samples are stored in a FD (flash disk or flexible disk), or the like. The FD is sent by mail, or the like. The results of summarizing the data are subjected to statistical processing. If a calculated value largely deviates from an average value, the measured results and the diagnostic results are sent to each hospital. Each hospital can use them as indicators of the quality control of a clinical laboratory.
(3) In the Case where Public Institutions Including a Medical Association Distribute Control Samples
Public institutions including the Japan Medical Association distribute, all at once, nationwide common control samples to hospitals, clinical laboratory test centers, and the like, in Japan, about once or twice a year. The control samples which have been distributed to each of facilities by each analyzer are measured. Then, the measured results are transmitted to the Japan Medical Association so that the measured results are subjected to statistical processing. An average value and a standard deviation are calculated. Then, according to the deviation from the average value, the measured results are judged to be A (±1 SD (standard deviation), B (±2 SD), C (±3 SD), D (±4 SD). The results of the judgment are transmitted to the director of each hospital.
Besides the Japan Medical Association, the above-described method is carried out on a prefecture basis, and on a hospital group basis.
2. Control System of Analyzer
Some analyzer manufacturers for manufacturing automated analyzers, and the like, also put to practical use a system in which each analyzer manufactured by the analyzer manufacturer, which has been sold to each hospital and is located at the hospital, is connected to for example a server controlled by a service division of the analyzer manufacturer through a network line so that a state of the analyzer is remotely monitored. FIG. 1 is a diagram schematically illustrating a configuration of the whole system.
Information handled by this system includes: (1) information that is transmitted from the system of the support center to each automated analyzer; and (2) information that is transmitted from each automated analyzer to the system of the support center. In addition, the information handled by the system further includes: (3) information that is transmitted thorough the network line when each of facilities makes an inquiry to the system so as to check information controlled on the system side. Thus, the information handled by the system includes the three kinds of information.
Although there are the three kinds of information, information handling methods differ depending on analyzer manufacturers. Fore example, some analyzer manufacturers only answer a question using a network line. There are also analyzer manufacturers that support the flow of information only in one direction; more specifically, only the occurrence of an abnormal condition of an analyzer is transmitted from the analyzer to a service center.
A general example of the three kinds of information will be described as blow.
(1) Information to be Transmitted from the System of the Support Center
The support center transmits the following information:                analysis parameters for each item;        standard solution concentration for each item;        an average value, and a standard deviation, on a control sample basis(2) Information to be Transmitted from Each Automated Analyzer to the Support Center        
From each analyzer located in each facility such as a hospital, this system extracts basic information including: alarm information including an abnormal condition of an analyzer; the results of measuring control samples; the measured absorbance of standard solution; and the results of calibration. The above information is accumulated in an information center.
(a) alarm information including an abnormal condition of an analyzer
an abnormal condition of an electric circuit, or that of a machine, which has occurred in an analyzer
(b) the results of measuring control samples
the results of measuring each control sample; and a reagent lot, a control sample lot, and the like
(c) the results of calibration
the results of measuring standard solution
(a) measured data                the measured absorbance of each standard solution (dominant wavelength, secondary wavelength)        the initial absorbance        
(b) calculation parameter                K factor        S1ABS(3) Data Summarizing Method of a Data Center        
The information center summarizes data of control samples on a facility basis to compare average values, and summarizes standard deviation information.
summarization on a facility basis                an average value        between-run reproducibility        a standard deviation        
An inquiry about the data and the information is responded by use of a network line. For example, if the alienation of data is extraordinarily large, a comment about an improvement method, or the like, is transmitted. In addition, if it is not possible to understand how to handle an analyzer, services including a response to an inquiry are also provided. The results of controlling the standard solution are illustrated with a graph.
A technology relating to the above, for example which is described in patent document 1 (WO 02/052278A1), has been applied for a patent.